Registration and Labelling

Any product labelled as a disinfectant in the United States must be registered with the U.S. Environmental Protection Agency (EPA). Antimicrobial registration falls under the U.S. EPA Pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (40 CFR Parts 150-189). Chemical disinfectants are considered antimicrobial pesticides intended to destroy or suppress the growth of harmful microbiological organisms, and pesticides that protect inanimate objects and surfaces from organisms such as bacteria, viruses, or fungi. EPA Regulations require these products to provide data supporting the product chemistry, toxicity, and efficacy claims. All tests must be performed in accordance with the U.S. EPA protocols. All documents and label must be approved by the U.S. EPA and assigned an U.S. EPA registration number. Antimicrobial products may not make efficacy claims against any pathogen unless the agency has reviewed data to support the claim and approved the claim on the label.

Toxicity

Disinfectants are tested for toxicity to determine the Toxicity Category they fall under. The Category in turn will determine what signal or label warnings must be on the product label. There are currently four toxicity Categories with I (1) being the most toxic and IV (4) being the least toxic. The following table show the signal words that must appear on the label for each of the U.S. EPA Toxicity Categories.

U.S. EPA TOXICITY CATEGORY – REQUIRED SIGNAL WORDS FOR LABELS

SIGNAL WORDCATEGORYORAL LETHAL DOSE
DANGER, POISON, Skull and Crossbones I (Highly Toxic)A few drops, to a teaspoonful
WARNING II (Moderately Toxic)Over a teaspoonful to one ounce
CAUTION III (Slightly Toxic)Over one ounce to one pint
NONE REQUIRED IV (Relatively Non-Toxic)Over one pint to one pound

Important facts when performing Disinfection and/or choosing a disinfectant

Contact Time (Dwell Time)

This is the time that the surface needs to remain visibly wet to ensure the effectiveness of the product. This is critically important to the success of eliminating microbial contamination. The contact time varies from product to product and may be anywhere from 2 – 10 minutes. Many disinfectants evaporate on surfaces before they have a chance to completely kill pathogens. This inevitably results in cross-contamination of surfaces. This is something to consider when using disinfectant wipes. While the convenience of using a pre-moistened wipe to disinfect surfaces is appealing, if you note the required contact time on the label you will find that the product evaporates long before the contact time expires. In this case you will need to use multiple wipes to ensure that the surface remains visibly wet for the entire contact time.